FDA product code LCW: Radioimmunoassay, Digitoxin (125-I)
LCW is the FDA product code for radioimmunoassay, digitoxin (125-i). It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LCW, from 3 different applicants. The average 510(k) review took 58 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digitoxin (125-I) |
| Device class | Class II |
| Regulation | 21 CFR 862.3300 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCW clearance
Top LCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cambridge Medical Technology | 1 | 1984-02-04 |
| Immunotech Corp. | 1 | 1980-10-31 |
| Diagnostic Products Corp. | 1 | 1978-07-27 |
Most recent LCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834080 | Cambridge Medical Technology | MATCHED COMPONENT SET FOR DIGITOXIN | 1984-02-04 | 68 |
| K802461 | Immunotech Corp. | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT | 1980-10-31 | 23 |
| K780766 | Diagnostic Products Corp. | (125 I) DIGITOXIN RIA KIT | 1978-07-27 | 83 |
Recalls for LCW devices
openFDA lists no recalls for product code LCW.
Frequently asked questions
What is FDA product code LCW?
LCW is the FDA product code for radioimmunoassay, digitoxin (125-i). It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is LCW?
Class II, regulation 21 CFR 862.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCW?
Across 3 cleared submissions the average was 58 days from receipt to decision (median 68).
Which companies have the most LCW clearances?
Cambridge Medical Technology (1); Immunotech Corp. (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCW
- Run a recall and safety report across every LCW manufacturer
- Watch product code LCW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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